Senior Quality Assurance Engineer

IrishJobs

Galway, Galway, Ireland

Galway, Galway, Ireland

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As a Senior Quality Assurance Engineer, you will play a key role in ensuring product quality, regulatory compliance, and effective quality system implementation across both production and New Product Development (NPD) / New Product Introduction (NPI) activities. You will work closely with cross-functional teams to support quality processes, drive continuous improvement initiatives, and ensure products and processes meet customer, regulatory, and internal requirements Key Responsibilities: Provide Quality Assurance support across manufacturing and NPD/NPI activities, ensuring compliance with Quality Management System (QMS) requirements and applicable regulatory standards. Support client programmes involving the development and implementation of new products, materials, and processes, including associated quality documentation. Review and approve quality documentation to support pilot builds, scale-up activities and successful transfer to production. Conduct and support risk management activities, including DFMEA and PFMEA, ensuring effective identification and mitigation of quality risks. Manage and support core quality processes including CAPA, non-conformance management, change control and product release activities. Partner with cross-functional teams to investigate quality issues, identify root causes and implement effective corrective and preventive actions. Support internal, customer, and supplier audits, including the management and closure of audit findings. Review and approve procedures, work instructions, and quality records to ensure compliance and accuracy. Interface with customers and suppliers on quality-related matters, maintaining strong professional relationships. Support supplier quality activities, including supplier qualification and performance monitoring. Ensure documentation is maintained in accordance with QMS and regulatory requirements across both development and commercial operations. Contribute to continuous improvement initiatives aimed at enhancing product quality, compliance, and operational effectiveness. Support site audit readiness activities and regulatory inspections as required. Requirements: Bachelors Degree in Engineering or a related technical discipline. Minimum 10 years Quality Assurance experience within the medical device industry. Proven experience supporting New Product Development (NPD) and New Product Introduction (NPI) activities. Strong working knowledge of ISO 13485, FDA QSR, and medical device quality system requirements. Demonstrated experience with CAPA, non-conformance management, change control, and quality investigations. Experience supporting internal, customer, supplier, and regulatory audits. Strong understanding of risk management principles, including DFMEA and PFMEA. Experience working within both development and manufacturing environments. Familiarity with electronic Quality Management Systems (eQMS) is advantageous. Excellent communication and stakeholder management skills. Strong organisational skills with the ability to work independently and manage multiple priorities. For a confidential conversation about the role please apply for the role or contact Owen Clancy at By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

TLNT1_IJ

Galway, Galway, Ireland

Sprachkenntnisse

English

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